FDA WARNING_LETTER - electric freedom inc - April 27, 2021

The FDA's Center for Tobacco Products issued a Warning Letter to Ron MacDonald of Crown7 on April 23, 2021, following a review of their website, crown7.com. The FDA determined that Crown7 manufactures and offers for sale or distribution e-liquid products, specifically "Crown7 Spartan Liquid – Apple Medley" and "Crown7 Spartan Liquid – Strawberries & Cream," to U.S. customers.

These e-liquid products are classified as "new tobacco products" under section 910(a) of the FD&C Act because they were not commercially marketed in the U.S. as of February 15, 2007. The FDA found that these products lack the required premarket marketing authorization order under section 910(c)(1)(A)(i) of the FD&C Act and are not otherwise exempt. Consequently, these products are deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act, as no notice or information was provided per section 905(j).

Crown7, a registered manufacturer with over 80 products listed with the FDA, is responsible for ensuring compliance. The FDA requires a written response within 15 working days detailing actions taken to address violations, including discontinuing the sale and distribution of the non-compliant products, and a